Radiopharmaceutical Manufacturing Associate

NorthStar Medical Radioisotopes, LLC; Golden Horseshoe; On-site; USD 50,000 - 80,000; Full time

Job summary

An innovative company in the pharmaceutical industry is seeking a Radiopharmaceutical Manufacturing Associate to join their dynamic team. This role involves supporting the development and manufacturing of radiopharmaceuticals, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. With a focus on professional growth, the company offers a stimulating work environment and opportunities for career advancement. Employees enjoy competitive compensation, comprehensive benefits, and a chance to make a significant impact in oncology treatment. Join a forward-thinking organization dedicated to revolutionizing patient care through cutting-edge technology and collaborative teamwork.

Benefits

Health Insurance

Life Insurance

401K Match

Paid Holidays

Paid Time Off

Paid Parental Leave

Annual Bonus

Equity Incentive Plans

Qualifications

• Minimum Associate's Degree in a STEM discipline or equivalent experience.
• Preferred Bachelor's Degree in STEM with cGMP experience.

Responsibilities

• Execute radiopharmaceutical manufacturing processes and maintain records.
• Perform safety checks and maintain cleanliness in manufacturing areas.

Skills

Customer Focus

Proactivity

Collaboration

cGMP Principles

Technical Skills

Education

Associate's Degree in STEM

Bachelor's Degree in STEM

Job description

Overview

Accelerate your career with NorthStar!

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner. We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities.

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, paid parental leave and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position

The Radiopharmaceutical Manufacturing Associate performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.

This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required. Early morning, late evening, weekend, and some holiday work will be required with occasional overtime. Requirements for this position include the ability to work 1st, 2nd, and 3rd shifts.

Responsibilities

• Execute various aspects of radiopharmaceutical manufacturing, including pre-production set-up, manufacturing processes, and post-production activities.
• Assist in the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
• Perform safety checks and routine inspection of the production processing equipment, consumables, and cleanrooms to ensure effective production. Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.
• Receive and track inventory of materials and consumables, and equipment list and report any deficiencies to the leader.
• Perform and assist in maintaining the cleanliness and orderliness of the cleanroom and/or manufacturing spaces, equipment, and materials in accordance with NorthStar’s respective policies and procedures.
• Support troubleshooting of manufacturing equipment and process issues, and escalating manufacturing, safety, and compliance issues.
• Support interdepartmental projects including production scale-up and continuous process improvement.

After 3 months, you will:

Understand foundational cGMP and just-in-time radiopharmaceutical manufacturing principles

Become a qualified Radiation Worker, trained in ALARA principles and isotope-specific safety protocols.

Collaborate effectively with cross-functional teams, including Quality, Science, and Engineering, to ensure timely delivery of radiopharmaceuticals for cancer treatment.

Gain hands-on experience with state-of-the-art manufacturing technology under expert supervision.

After 6 months, you will:

Achieve Qualified Operator status with demonstrated competency to execute full batch manufacturing of novel isotopes.

Contribute to Operational Excellence by maintaining optimum KPIs and metrics to enhance production efficiency and quality.

Fully integrate into NorthStar’s mission to revolutionize oncology treatment by providing patients with global access togame-changingradiopharmaceuticals.

Develop advanced technical skills in handling sophisticated manufacturing processes and technologies, positioning yourself as a key player in an innovative and impactful field.

Qualifications

Minimum Education/Experience

Associate’s Degree (AS) in a STEM discipline; or equivalent combination of education and experience. Relevant military experience will also be considered.

Preferred Education/Experience

Bachelor’s Degree (BS) in a STEM discipline and minimum one (1) year of cGMP experience.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9.

Working Conditions

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures. The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions. Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols. This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment. In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders.

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

Location

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.